Medical Devices and Diagnostic Products that May Contain or Be Coated with Heparin This list is not meant to be exhaustive and will be updated as additional information becomes available. It is for information purposes only. FDA does not mean to suggest, in any way, that the products herein have been or are affected by contaminated heparin. Items in [brackets] are in-vitro diagnostic products.
| Manufacturer or Distributor | Product |
|---|---|
| 3M Health Care | 3M CDI Quick-Cells with Heparin Treatment |
| 3M Sarns Flow Sensor , Centrifugal Control Module | |
| Sarns Arterial Cannulae with Duraflo Treatment | |
| Sarns Venous Return Catheters with Duraflo Treatment | |
| A-Med Systems, Inc. | Heparin Coated Miniature Centrifugal Bypass Pump |
| AMO Groningen BV | CEEON Heparin Surface Modified UV Light-Absorbing Posterior Chamber IOLs |
| CEEON Heparin Surface Modified UV Light-Absorbing Anterior Chamber IOLs | |
| Akers Labs | [Platelet Factor 4 RIA] |
| Alsius | Coolgard and catheter thermal regulation system |
| Thermogard System | |
| ICY Catheter Models IC3583 and IC3893 | |
| Quattro Catheter IC4593 | |
| Fortius Catheter | |
| AM2 PAT Inc. | Sierra Heparin Flushes |
| American Bentley | Heparin Coated Arterial Blood Filters |
| Heparin Coated Extracorporeal Circuits | |
| American Edwards Laboratories | Heparin Coated Catheter |
| Swan-Ganz Heparin Coated Catheter | |
| American Bioproducts | [Ptt-Lt] |
| [Stachrom Heparin] | |
| American Dade | [Lithium Heparinized Blood Collect-Tube] |
| [Actin Fs APTT] | |
| American Diagnostica | [Actichrome Heparin] |
| Amsino Medical USA | Heparin Flushes |
| APP | Heparin Flushes |
| Argon Medical Corporation | Heparin Coated Stainless Steel and Teflon Heparin-Coated Guidewires |
| Heparin Coated Thermodilution Catheters | |
| Arrow International, Inc. | Arrow-Howes large bore multi-lumen central venous catheter |
| HANDS-OFF Heparin Coated Thermodilution Catheters | |
| Artefactos De Vidrio S.A. De C.V. | [Ven-O-Vac Blood Collection Vacuum Tubes] |
| Atrium Medical | Atrium Heparin Coated Catheters |
| Avecor Cardiovascular Inc. | Affinity Hollow Fiber Oxgenator with Trillium Biopassive Surface |
| Avitro LLC | Heparin Flushes |
| B. Braun of America | H.E.L.P System |
| Heparin Flushes | |
| Baxter Bentley Laboratories | Duraflo II Heparin Treated Suction Wands |
| Duraflo II Heparin Treated Femoral Cannulae | |
| Baxter Edwards | Carpenter-Edwards Classic Ring with Duraflo Treatement |
| Baxter Healthcare Corp. | Hep-LOCK Heparin Flushes |
| Becton Dickson | B-D Heparinized Longdwel IV Catheter |
| Heparin Coated Thermodilution Catheter | |
| Heparin Coated Luminal Pacing Catheter | |
| Heparin Flushes | |
| [Vacutainer Brand Plus Sodium Heparin Tube] | |
| [Bd Vacutainer Plus Pst Ii Tube] | |
| [Vacutainer Brand Blood Collection Syringe] | |
| Bio/Data Corp | [Cephalinex APTT] |
| Biosensors Intl PTE, LLC | Heparin Coated Thermodilution Catheters |
| Biotrack, Inc | Biotrack APTT |
| Boston Scientific Corp | Constellation Multiple Electrode Pacing and Recording System |
| Cardiac Assist, Inc. | TandemHeart Transseptal Cannula Set-EF |
| Cardiovascular Diagnostic Services | [Aoag-1 APTT Test Card] |
| Cardiovascular Diagnostics | [(Tas) Low Range Heparin] |
| Careside Hemotology | [APTT] |
| Celsus | Heparin Flushes |
| Ciba Corning Diagnostics Corp. | [Ciba Corning Blood Collection Capillary Tube] |
| Coaxia Inc | Coaxia Neuroflo Catheter |
| COBE Laboratories | Heparinized Arterial Screen Blood Filter |
| Sentry Smarxt 43 Micron Arterial Filter | |
| Smarxt BMR 1900 Closed Venous Reservoir Bag | |
| Smarxt VVR 4000 Filtered Hardshell Venous Reservoir | |
| Smarxt VVR4000I Plus Filtered Hardshell Venous Reservoir | |
| Smarxt HVR 4000 Surface Modified Hardshell Venous Reservoir | |
| Closed Venous Reservior Bags with Smarxt | |
| Sorin Biomedica Smarxt BCD Vanguard Surface Modified Blood Cardioplegia System | |
| Smarxt Optimin Surface Modified Hollow Fiber Membrane Oxygenator | |
| Smarxt Optima XP Surface Modified Hollow Fiber Membrane Oxygenator | |
| CML Duo with Smarxt Surface Modified Membrane Oxygenator | |
| Smarxt Tubing and Connectors | |
| Cook, Inc | Amplatz Heparin Coated Catheter |
| Cordis | BX Velocity with Hepacoat Coronary Stent |
| Covidien | Heparin Flush Solutions |
| Palindrome Emerald 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating | |
| 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve (Palindrome Sapphire) | |
| Critikon Company, LLC | Heparin-Coated Balloon Thermodilution Catheters |
| Current Technologies Inc. | [Arterial Micro Collection Kit] |
| [Prefilled Arterial Blood Sampling Syring] | |
| Dade Behring, Inc. | Dimension Vista System Drugs of Abuse Calibrator |
| Dade, Baxter Travenol | [Heparin Assay] |
| Daig Corp | Heparin Bonding for Cathteters |
| Datascope Corp | Percluder-DL Occluding Balloon Heparin Coated |
| Diagnostica-Stago | [Rotachrom Heparin] |
| Dupont Medical Products | [Dupont Apc Blood Collection Container With Lithiu] |
| Edwards Lifesciences | Embol-X Intra-Aortic Filter |
| Heparin Coated Arterial Blood Filters | |
| Retrograde Cardioplegia Cannula with Duraflo | |
| PediaSat Oligon Oximetry Catheters with AMC Thromboshield Heparin Coating | |
| PreSep Oligon Oximetry Catheters with AMC Thromboshield Heparin Coating | |
| Polyethylene Central Venous Catheter with Heparin Coating | |
| Swan-Ganz and Edwards Laboratories Heparin Coated Catheters | |
| Edwards Vantex Central Venous Catherer with Thromboshield Coating | |
| Edwards AVA 3Xi Device with Thromboshield Coating | |
| Edwards AVA High-Flow Device with Thromboshield Coating | |
| Edwards IntroFlex Percutaneous Sheath Introducer with Thromboshield Coating | |
| Venous Reservoir Bag Model No. BMR-800 with Heparin | |
| Venous Reservoir /Cardiotomy Autotransfusion Filter | |
| Duraflo II Heparin Oxygenator Model Univox Gold | |
| Univox Gold Membrane Oxygenator with Duraflo | |
| Extracorporeal Circuit with Duraflo II Heparin Treatment | |
| Sarns Centrifugal Pump with Duraflo II Treatment | |
| Jackson-Pratt Gold Wound Drains with Duraflo II | |
| Bentley Quick-Prime Hemoconcentrator with Duraflo Treatment | |
| Electro-Catheter Corp | Elecath Heparin-Coated Catheters |
| Elecath Heparin-Coated Temporary Pacing Catheters | |
| Elecath Heparin-Coated Thermal Dilution Catheters | |
| Em Diagnostics | [Easy-Test PTT] |
| Embol-X, Inc. | Embol-X Aortic Filters |
| Aortic Cannula Metal J-Tip (24 Fr) | |
| Embol-X Aortic Occlusion and Carioplegia Cannula | |
| Embol-X Introducer Model CF00200 | |
| Emisphere Technologies, Inc | Heparin Flushes |
| EV3 | Spiderfx Embolic Protection Device |
| Excelsior Medical | Heparin Flushes |
| GISH Biomedical, Inc. | GISH Tubing and Connectors with GBS Coating |
| GISH Arterial Filter with GBS Coating | |
| GISH ATR2900 and CAP35 Series Reservoirs with GBS Coating | |
| V-Bag with GBS Coating | |
| GISH CAPVRF44 Hardshell Venous Reservoir Ba with GBS Coating | |
| Soft Venous Reservoir (SVRXX) with GBS Coating | |
| IBC Flopump with GBS Coating | |
| Vision Blood Cardioplegia System and Extracorporeal Heat Exchanger with GBS Coating | |
| Gould, Inc. | Heparin Coated Thermodilution Catheters |
| Greiner Bio-One | [Greiner Vacuette Blood Collection Tube W/Lithium] |
| [Vacuette Evacuated Blood Collection Tubes] | |
| Greiner Meditech Inc. | [Greiner Minicollect Li Heparin Gel] |
| [Greiner Minicollect Lithium Heparin Gel Blood Col] | |
| Guidant Corp | Neurolink System |
| Helena Laboratories | [Chrom Z-Heparin] |
| [APTT-ES] | |
| Hospira, Inc. | Opticath Central Venous Oximtery Probes |
| Latex-free Advanced Sensor Catheters | |
| Flow-Directed Heparin Coated Thermodilution Catheter | |
| Opticath Catheter | |
| Opticath Heparin Coated Flow Directed Catheter | |
| Oximetrix Flow Directed Thermal Dilution Catheter | |
| Hyphen Biomed | [Biophen Heparin 3,6] |
| Infusaid Corp | Heparin Lock Maintenance Kit |
| Innerdyne, Inc. | Innerdyne Radially Expanding Vascular Access System |
| Instrumentation Laboratory Co | Heparinized Flow Directed Thermal Dilution Catheter |
| [Il Test] | |
| [Coamatic Heparin] | |
| International Technidyne (ITC) | [Hemochron Jr] |
| [Hemochron Kaolin-Activated Heparin] | |
| Intervascular, Inc. | Intergard Knitted Collagen Coated and Heparin Bonded Vascular Protheses |
| Intergard Knitted Ultra-Thin Collagen Coated and Heparin Bonded Vascular Protheses | |
| J-Lloyd Medical, Inc. | Flow Direct Thermodilution Balloon Catheter with Heparin Coating |
| Johnson & Johnson | Arterial 20/40 Micron Filters with Heparin Coating |
| KMA Inc. | Heparin Coated Thermodilution Catheter |
| Maquet Cardiopulmonary AG | Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating |
| Mansfield Scientific | Heparin Coated Temporary Pacing Electrode |
| Martech Medical Products Inc. | [Marksman Arterial Blood Gas Syringe] |
| Medefil, Inc. | Heparin Flushes |
| Medelec Intl. Corp. | [Blood Specimen Collection Devices] |
| Medical Components, Inc | MedComp DUO-COAT Catheter Double Lumen |
| Medrad, Inc. | Benzalkonium-Heparin Coated Guidewires |
| Medtronic | Trillium Bio Disposable Blood Flow Probe |
| Trillium Tri-Optic Measurement Cell | |
| Trillium Affinity NT Cardiotomy Venous Reservoir | |
| Trillium Biopump Plus Model BPX80T | |
| Affinity 20 Micron Arterial Filter with Trillium Biosurface | |
| Affinity 38 Micron Arterial Filter with Trillium Biosurface | |
| Select 3D (and CAP) Arterial Cannula with Carmeda Boactive Surface | |
| Affinity Pediatric Arterial Filter | |
| Affinity NT Hollow Fiber Oxygenator | |
| Trillium Myotherm XP Cardioplegia Delivery System | |
| Tubing and Connectors with Trillium Biopassive Surface | |
| Carmeda or Trillium Coated Myotherm Blood Cardioplegia System | |
| Carmeda Coated Intersept Pediatric Arterial Filter | |
| Minimax/Maxima Hollow Fiber Oxygenators | |
| Minimax Oxygenation System | |
| Mentor Corp | Mentor Tissue Expanders with TDMAC Coating |
| Microbio-Medics Inc. | [Microtek Medical`S Blood Collection Kit] |
| Millenia Healthcare, Corp. | Heparin Flushes |
| Morris innovative Research, Inc. | Femoral Introducer Sheath and Hemostasis (FISH) Device 5, 6, and 8 French |
| Nova Medical Speicialties | Heparin Coated Balloon Thermodilution Catheters |
| Novalung GMBH | Novalung Surgical Lung Assist (SLA) Membrane Lung |
| Organon Teknika | [MDA Heparin Anti-X] |
| Ortho | [Synthafax] |
| Oximetrix Inc. | Opticath Heparin Coated Flow Direct Catheter |
| Pacific Hemostasis | [Thromboscreen APTT] |
| Parke-Davis Co. | Deseret Heparin Coated Flow Catheters |
| Parker Pharmaceutical, Inc. | Heparin Flushes |
| Physician Industries, Inc. | PICC Insertion Tray with Hep-LOCK Heparin Flush |
| Precision Biologicals | [APTT Reagent] |
| Radiant Medical | Radiant Medical Endocatheter Temperature Probe |
| Setpoint Endovascular Temperature Management System | |
| Reprieve Endovascular Termperature Therapy System | |
| Radiometer Medical Aps | [Safepico] |
| Ram Scientific | [Safe-T-Fill Capillary Blood Collection System] |
| Research Industries Corp. | Duraflo II Heparin Treated Cannulae |
| Research Medical. Inc. | TDMAC-Heparin Coated RMI Carotid Bypass Shunt |
| Rocap/Sabratek Corp | Heparin Flushes |
| Roche Diagnostics | [Coaguchek] |
| Safety Diagnostics Inc. | [Pinset] |
| Shapes | Heparin Flushes |
| Shelhigh, Inc | Delcol Heparinized Pericardial Substitute |
| Sherwood Medical Co. | Argyle Griffith TDMAC Heparinized Veno-venous Shunt |
| Heparinized Wound Suction Tubing | |
| Heparinized Saratoga Sump Drain | |
| Heparinized Penrose Tubing | |
| Heparinized Intravenous Cannula | |
| [Lancer Coagent APTT] | |
| [Monoject Sample Capillary Plasma Sep W/Lith Hepar] | |
| [Monoject Samplette Capillary Blood Coll] | |
| [Monojet Sps Blood Collection Tube] | |
| Sigma | [APTT Reagent] |
| Sims Portex Inc. | [Pro-Vent Pulsator Arterial Blood Sampling Syring] |
| Smith's Healthcare Manufacturing | Injection Adaptor Heparin Lock |
| Smiths Industries Medical Systems Inc. | [Sims Pro-Vent 250 (500) Plus Arterial Blood Sample] |
| Smith's Medical ASD | Injection Adaptor Heparin Lock |
| Solo Pak Labs | Heparin Flushes |
| Sorenson Research | Flow-Directed Heparin Coated Thermodilution Catheter |
| Spectramed, Inc. | Heparin Coated Luminal Pacing Catheter |
| Spire Biomedical, Inc. | 15.5 Fr Decathalon Coated Catheters |
| Starplex Scientific Inc. | [Vacuplus Tubes With Green Stoppers] |
| Statspin Technologies | [Statspin Statsampler] |
| Sunscope Intl, Inc. | Heparin Coated Thermodilution Catheter and Accessories |
| Terumo Corp. | [Capiject Sys Capillary Blood Collect] |
| [Venoject Ii Blood Collection Tubes] | |
| Vital Scientific | [APTT] |
| Vital Signs, Inc | Heparin Flushes |
| W.L. Gore & Associates, Inc. | Gore Propaten Vascular Graft |
| Gore Viabahn Endoprosthesis with Heparin Bioactive Surface | |
| Wako Intl. Inc. | [Seri-Sep Serum/Plasma Islolator] |
Updated June 23, 2008
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